MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for ANGEL CONC PLT RICH PLASMA CPRP SYS US ABS-10060 manufactured by Arthrex, Inc..
[124671730]
Complaint could not be confirmed. The as-received condition prohibited the functional testing and evaluation of the device, as the abs-10060 was returned in an uncleaned, biohazardous state. No root cause could be determined.
Patient Sequence No: 1, Text Type: N, H10
[124671731]
It was reported at the start of a rotator cuff prp injection in clinic procedure, 180mml of blood was drawn, and the physician started the spin on the abs-10060, arthrex angel (sn: (b)(4)). It was reported that the machine sounded normal, and was operating as it should. The physician walked out of the room briefly and when they returned they discovered that there was blood all over inside the machine. The patient told the physician that they heard a loud audible pop right before the incident occurred. The rep confirmed that there was a small amount of blood that leaked through the lid, dripped down the back side of the machine, on to the table and on to the power cord. The arthrex angel prp kit abs-10061t that was used with the arthrex angel was from lot: 821985373. The rep stated that there was a second machine available. A second draw and spin was performed and the prp injection was completed without any issues. The rep stated that the spilled blood was cleaned by using "pabiwipes". The rep confirmed that the patient, nor any staff member was exposed or harmed by the spilled blood. The rep confirmed that the abs-10060 (sn: (b)(4)) is returning with the abs-10061t (lot: 821985373) still loaded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00707 |
| MDR Report Key | 7992148 |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2018-06-25 |
| Date Added to Maude | 2018-10-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANGEL CONC PLT RICH PLASMA CPRP SYS US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2018-10-22 |
| Model Number | ANGEL CONC PLT RICH PLASMA CPRP SYS US |
| Catalog Number | ABS-10060 |
| Lot Number | 10219671 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Brand Name | ANGEL CONC PLT RICH PLASMA CPRP SYS US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2018-10-22 |
| Model Number | ANGEL CONC PLT RICH PLASMA CPRP SYS US |
| Catalog Number | ABS-10060 |
| Lot Number | 10219671 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-22 |